Condition category
Infections and Infestations
Date applied
03/08/2016
Date assigned
11/08/2016
Last edited
11/08/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Septic shock is a life-threatening condition in which the blood pressure drops to dangerously low levels because of a serious blood infection (sepsis). Children are now much more likely to survive a septic shock than ever before. This progress comes from a whole package of treatments including antibiotics, multiple rapid doses (boluses) of fluid (saline (salt water) solution) into a child’s veins (‘fluid bolus therapy’) and support for breathing and heart function. This study is looking at refining the fluid bolus therapy part of this package by exploring what the best amount of fluid to give in the earliest stages of treatment is. In order to explore this, the study will monitor children to find out if giving less fluid per bolus to children with symptoms of a septic shock is better than giving a higher amount of fluid, as currently recommended. The aim of this study is to conduct a small version of the study to find out how feasible the study methods are and to find out if it is possible to recruit enough children to take part.

Who can participate?
Children under 16 years of age who are showing signs of septic shock, their parents or legal guardians, and hospital research teams.

What does the study involve?
In the first part of this study, children are randomly allocated to one of two groups. Those in the first group receive the current recommended bolus (dose) fluid therapy, of 200 ml/kg (maximum 1000 ml per bolus) every 15 minutes for four hours, until the signs of shock have gone or there are signs of fluid overload (a condition where there is too much fluid in the blood). Those in the second group receive smaller boluses of 10 ml/kg (maximum 500 ml per bolus) according to the same schedule. The type of fluids and other treatments given are left up to the medical team to decide. For both groups, the amount of fluid given to the children is recorded. In the second part of the study, parents/legal guardians of children participating in the first part of the study complete a number of questionnaires and telephone interviews to find out their views on the study process. Three focus groups with the hospital research teams are also held to explore their experiences of the study processes and consenting parents/legal representatives to the first part of the study.

What are the possible benefits and risks of participating?
It is not known whether there will be any additional benefits involved with participating in this study, however this study will help to improve the future treatment of children with septic shock. There are no notable risks involved with taking part.

Where is the study run from?
Fourteen NHS children’s hospitals in England (UK)

When is the study starting and how long is it expected to run for?
December 2015 to April 2017

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
1. Dr David Inwald (scientific)
2. Ms Ruth Canter (public)
ruth.canter@icnarc.org

Trial website

https://www.icnarc.org/Our-Research/Studies/Fish/About

Contact information

Type

Scientific

Primary contact

Dr David Inwald

ORCID ID

Contact details

Paediatric Intensive Care Unit
Queen Elizabeth The Queen Mother (QEQM) Wing
St Mary's Hospital
Praed Street
London
W2 1NY
United Kingdom

Type

Public

Additional contact

Ms Ruth Canter

ORCID ID

Contact details

ICNARC CTU
Napier House
24 High Holborn
London
WC1V 6AZ
United Kingdom
+44 207 269 9277
ruth.canter@icnarc.org

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

16SM3292

Study information

Scientific title

External pilot study of the Fluids in Shock (FiSh) trial

Acronym

FiSh Pilot Study

Study hypothesis

The aim of this study is to explore and test important key parameters needed to inform the design and ensure the successful conduct of the FiSh trial.

Ethics approval

London - Stanmore Research Ethics Committee, 14/06/2016, ref: 16/LO/0854

Study design

Mixed methods:
1. Multicentre, pragmatic, open, pilot randomised controlled trial
2. Qualitative questionnaires, interviews and focus groups

Primary study design

Other

Secondary study design

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

No participant information sheet available

Condition

Sepsis/Septic shock

Intervention

Patients are randomised 1:1 using sealed opaque envelopes available at each site.

Intervention: Restrictive bolus fluid resuscitation of 10 ml/kg (maximum 500 ml per bolus)
Control: Current recommended bolus fluid resuscitation of 20 ml/kg (maximum 1000 ml per bolus)

Fluids to be delivered every 15 minutes for four hours, until clinical signs of shock has resolved or there are signs of fluid overload. Type of fluid and all other treatments are at the discretion of the treating clinician.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Feasibility of the intervention processes is determined by the evaluation of all the secondary outcomes at the end of the study, including a recommendation, or not, to continue to a larger trial.

Secondary outcome measures

1. Eligibility rate is measured using the proportion of eligible patients randomised, as recorded on the screening and enrolment log at baseline
2. Recruitment rate is measured using the number of patients randomised per site per month, as recorded on the enrolment log and study database at baseline
3. Proportion of parents/guardians refusing deferred consent is measured using data recorded on the enrolment log and study database at hospital discharge or end of study (dependent upon timing of approach)
4. Proportion of fluid boluses delivered at correct volume and time during the intervention period is measured using data recorded on patient medical notes and the study database between randomisation and four hours post-randomisation
5. Total volume of fluid received during the intervention period is measured using data recorded on patient medical notes and the study database between randomisation and four hours post-randomisation
6. Proportion of complete data for each outcome measure is measured using data recorded on patient medical notes, the study database and linkage with routine data sources between randomisation and 30 days post-randomisation
7. Time taken for data collection and entry is measured using data from feedback from site staff during focus groups at the end of the study
8. Proportion of required data able to be linked to routine sources is measured using routine sources specification at the end of the study
9. Adverse events are measured using data recorded on patient medical notes and the study database between randomisation and 30 days post-randomisation

Overall trial start date

01/12/2015

Overall trial end date

30/04/2017

Reason abandoned

Eligibility

Participant inclusion criteria

Pilot RCT:
Children:
1. Age greater than or equal to 37 weeks (corrected gestational age) and less than 16 years
2. Clinical suspicion of infection
3. Clinical signs of shock after receipt of 20 ml/kg of bolus fluid
4. Recruitment and randomisation to take place while child is in an acute assessment area (e.g. emergency department, paediatric assessment unit (PAU))

Observational component:
Parent/Guardian inclusion criteria (questionnaire component):
Parent/Guardians who were approached for consent prior to hospital discharge

Parent/Guardian inclusion criteria (telephone interview component):
Parent/Guardians who were approached for consent

Site research staff:
Site research staff who are involved in screening, recruiting, randomising and consenting during the pilot RCT.

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

108

Participant exclusion criteria

Pilot RCT:
Children:
1. Prior receipt of more than 20 ml/kg of bolus fluid
2. Conditions in which bolus fluid resuscitation should be curtailed (e.g. raised intracranial
pressure, diabetic ketoacidosis, known/suspected myocarditis/cardiomyopathy)
3. Full active resuscitation not within current goals of care

Observational component:
Parent/Guardian exclusion criteria (questionnaire and telephone interview):
Parents/Guardians who do not speak English.

Recruitment start date

13/06/2016

Recruitment end date

31/03/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

St Mary's Hospital
Praed Street
London
W2 1NY
United Kingdom

Trial participating centre

Great Ormond Street Hospital for Children
Great Ormond Street
London
WC1N 3JH
United Kingdom

Trial participating centre

Bristol Royal Hospital for Children
Paul O'Gorman Building Upper Maudlin Street
Bristol
BS2 8BJ
United Kingdom

Trial participating centre

Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom

Trial participating centre

Chelsea and Westminster Hospital
369 Fulham Road
London
SW10 9NH
United Kingdom

Trial participating centre

Watford General Hospital
Vicarage Road Watford
London
WD18 0HB
United Kingdom

Trial participating centre

Whittington Hospital
Magdala Avenue
London
N19 5NF
United Kingdom

Trial participating centre

Queen Alexandra Hospital
Southwick Hill Road
Portsmouth
PO6 3LY
United Kingdom

Trial participating centre

Basingstoke and North Hampshire Hospital
Aldermaston Road
Basingstoke
RG24 9NA
United Kingdom

Trial participating centre

Royal Hampshire County Hospital
Romsey Road
Winchester
SO22 5DG
United Kingdom

Trial participating centre

Musgrove Park Hospital
Parkfield Drive
Taunton
TA1 5DA
United Kingdom

Trial participating centre

Royal Devon and Exeter Hospital
Barrack Road
Exeter
EX2 5DW
United Kingdom

Trial participating centre

Royal United Hospital
Combe Park
Bath
BA1 3NG
United Kingdom

Trial participating centre

Northwick Park Hospital
Watford Road
Harrow
HA1 3UJ
United Kingdom

Sponsor information

Organisation

Imperial College Heathcare NHS Trust

Sponsor details

Joint Research Compliance Office
5th Floor
Laboratory Block
Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
United Kingdom
+44 203 311 0212
jrco@imperial.ac.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

A comprehensive report recommending the continuation, or not, to the full FiSh trial will be submitted to the NIHR HTA programme for publication in Health Technology Assessment. The findings from both the feasibility and the external pilot study will be widely disseminated and published in appropriate, peer-reviewed, scientific journals and, if appropriate, relevant professional journals within one year of the overall study end date.

Following initial presentation of the results to the collaborating sites, the results will be presented at national and international conferences/meetings. The results of the combined feasibility and pilot study will be disseminated to families (children and their parents/guardians) via the Clinical Studies Group for Children (Anaesthesia, Pain, Intensive Care and Cardiology), facilitated by clinical co-investigators who sit on the group, and via the Young Person’s Advisory Group.

Intention to publish date

30/04/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes